TFS is a Global CRO headquartered in Sweden. We genuinely believe that “Global in mind and local at heart” is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.
The Start-Up Manager performs any/all of the following tasks and responsibilities, as well as any other tasks deemed appropriate by the Supervisor:
- Implementation of site identification and selection activities.
- Confirmation that all tasks required for activating a site are completed according to agreed standards, including but not limited to:
Logistic aspects (e.g. provision of study materials and documents, accesses to systems)
Compilation of documents required for activation (e.g. Site Activation Package).
Approval of country/site level informed consents prior to submissions
Contract and Budget negotiation
Site training requirements
- Responsible for the coordination (and information) of site activation activities until transfer to PM with all parties (including site, monitoring, QARA, CSU, PM, all other appropriate team members) to ensure site activation timelines are met. He/ she is responsible to detect and escalate country or site level issues that could impact site activation timelines
- In charge of site-level reporting (internally and externally)
- Scientific background is highly recommended
- Excellent knowledge of clinical research standards
- Experience in clinical research activities including relevant experience in site activation (e.g. monitoring)
- Ability to integrate to an international team and efficiently interact with colleagues
- Excellent organizational skills are required to supervise multiple parallel projects
- Competitive rate
- Possibility to extend the contract and to adapt FTE level
- Working from home
- Flexible hours